Recent media coverage has sensationalized the criminal
investigation of several cardiologists for the possibility of performing fraudulent
cardiac procedures.Is this a case of individuals
with unethical conduct? Or, does it point toward a more systemic problem in
medical care, where Medicare
dollars are wasted on unneeded care? As reported in Heartwire
on July 27, 2011:

"A federal jury convicted McLean, 59, on six charges
of healthcare fraud relating to insurance claims he'd filed for stents deemed
to have been placed unnecessarily, as well as for ordering unnecessary tests
and making false entries in patient medical records…evidence brought forward
suggested that McLean had performed cardiac catheterizations and implanted unnecessary
cardiac stents in more than 100 patients. He then falsely recorded in the patients'
medical records the existence or extent of coronary artery blockage, known as
lesions, observed during the procedures in order to justify the stent and the
submission of claims to healthcare benefit programs, including Medicare and Medicaid."

In a
separate case the Senate Finance
Committee investigated
Dr. Mark Midei, an interventional cardiologist practicing in Towson
Maryland, for
the possibility of performing unnecessary stents and also
for his relationship with Abbott Laboratories, the company that manufactures
the stents that he used.

“What was going on in Baltimore is going on right
now in every city in America,” saying
that he routinely treats patients who
have been given multiple unneeded stents. “We’re spending a fortune as a
country on procedures that people don’t need.”

Coronary artery disease affects a large proportion of people in
Western civilization. The disease manifests as blockages in coronary arteries limiting
blood flow to heart muscle, causing heart pain, heartattacks, heart failure and/or sudden death.
Heart disease kills 1 out of every 6 Americans. Coronary artery stents are metal
mesh tubes that can be placed in blocked coronary arteries completely reopening
them and improving blood flow to the heart muscle.Many studies (PAMI, TACTICS-TIMI 18,
etc.) have shown that when used appropriately, stents can be life-saving and
improve quality of life by relieving heart pains (angina) and preventing heart
attacks.

However, in 2007 the COURAGEtrial was published demonstrating that in some patients with coronary
artery disease, there was no mortality or heart attack benefit associated with
an initial treatment strategy of using stents, comparedwith medication treatment.The trial also found evidence that a strategy
of using medications alone could potentially save money. In considering these
results, several caveats must be kept in mind: patients included in the study
were very select (< 1 in 15 patients considered were actually studied); they
tended to have mild disease (78% had either no or only slight symptoms;
patients with recent heart attacks were excluded);~1/3 of patients initially treated with medications
alone eventually required stents for their blockages anyway.In addition, patients who underwent initial treatment
with stents had a quicker improvement in quality of life as compared to
patients who initially were treated with medications alone. Nonetheless, this single
study suggested that the need for coronary stenting is unnecessary in at
least some patients with coronary artery disease, and that trying medication therapy
alone in those patients is reasonable. There is ongoing investigation designed
to confirm or refute the observations of the COURAGE trial.

In a New York Times editorial entitled Cut
Medicare, Help Patients authors Ezekiel Emanuel and Jeffrey Liebman discuss
the use of cardiac stents for treatment of symptomatic coronary artery disease suggesting
that many stents are unneeded.

“Every year more than 1
million cardiac stents are placed in patients to open blocked arteries…many patients who receive stents paid for by Medicare
are either experiencing no pain or have not tried medication first.”

In a review of national registry data published this year in JAMA
by Chan et al. it was concluded that by current criteria 1 to 11.6 percent of
stents placed may have been “inappropriate” based in part
on the results of the COURAGE study.

It is important to distinguish between “unneeded care” due to
fraud and “unneeded care” due to less expensive but similarly effective
alternatives. Fraud implies dishonest intent. Unneeded care due to fraud is
universally considered to be wrong. In contrast, calling care unneeded because
there are less expensive and similarly effective alternatives is subject to a broad
range of opinion. In an article that I read recently Dr.
Maneesh Patel (Duke
Clinical Research Institute, Durham, NC) made the important point:

"the
majority of what we do in medicine is based on evidence that would fall into
the category of 'uncertain' "—for example, guideline recommendations with
level of evidence B or C.“

The Maryland cardiologists are accused fraud, or falsely recording
the presence of significant coronary artery disease, and billing health insurance
for placing stents in such patients. This is very different than choosing to
treat significant coronary artery disease with a stent when medical therapy
alone may also be a reasonable strategy in preventing death or myocardial
infarction (heart attack).

Here’s an example:a 50
year old man was found to have calcifications in his coronary arteries on a
chest CT done for follow up of cancer (presumed cured). On questioning, the
patient, who has high blood pressure, high cholesterol, and a family history of
heart disease, noticed some shortness of breath with exertion, potentially due
to obstructive coronary artery disease.An exercise treadmill test was ordered and was positive after ten
minutes.An exercise echocardiogram was
ordered and showed a possible small area of reduced blood flow after ten
minutes.A cardiac catheterization was
ordered and an 80 percent blockage of one artery was found. A stent was placed
and the patient was started on blood thinners.The patient also had 30 to 50 percent blockages in other locations and
was advised to take more cholesterol and blood pressure medication.

Which of the tests/treatments in this case were unnecessary? If
the coronary blockage was 40 percent and not 80 percent, the stenting here
would be universally considered to be unnecessary. (Furthermore, if the physician
knowingly reported this 40 percent blockage as 80 percent, stented it, and
billed for it, then it would constitute fraud). If the coronary artery blockage
was truly 80 percent then according to the results of the COURAGE trial, first
trying medical therapy alone could be as effective as immediately using stents
for the purposes of minimizing the cardiovascular mortality in this patient
(but perhaps not from the point of view of immediately relieving his symptoms).In this situation, the immediate stent
placement could also be considered “unnecessary.”

With a proposal to add “cost-conscious care and
stewardship of resources” as one of the ACGME’s core competencies for
medical trainees, and with Medicare aggressively tightening its belt in order
to remain fiscally solvent, determining “unnecessary care” will depend
on developing a consensus on the value of life, suffering, and the validity of
extrapolating scientific data analysis to a multitude of individual specific
patient situations.As health professionals and policy makers
appropriately engage in this discussion about what represents effective care
that health insurance should pay for, they should be careful not to equate outliers,
such as doctors facing criminal charges for fraud, with accepted variation in
standard practice that might encompasses care that some deem “unneeded.”Equating unneeded care with dishonest intent is
bound to elicit a highly emotional response from most doctors, who
are deeply committed to their professional obligation to do what they believe
is best for their patients.

2 comments:

It is both shocking and disturbing to know that there are some people who would readily abuse healthcare insurance and policies for their own personal gain. It really emphasizes the need to choose your doctor carefully.

I have been the recipitant to fraudulent health care by a cardiologist on the Sunshine Coast Queensland. I have had three cardiac stents fitted with no medical symptoms or tests to ascertain the correctness for this procedure to be performed. I had good blood pressure/no diabetes/ no heart attack/ stroke/ never smoked/ never over weight and very high exercise with good diet. My results under the protocol for the diagnosis and treatment of CAD was low risk, no medication prescribed and review the patient in 2 years time. I HAD DAMAGED A CHEST MUSCLE WITH HEAVY LIFTING, the stents are a legacy of trusting an overseas trained cardiologist who performed for the procedure for monetory gain only. John L

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I am a general internist, otherwise known as a primary care physician for adults. I grew up in Ann Arbor, Michigan, attended medical school at the
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